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More than 7 million women have sought fertility treatment. Individuals and couples looking for fertility treatments are already vulnerable and put all their hopes in the hands of seemingly informed doctors. Ineffective fertility treatments, such as the recalled Bravelle, can negatively affect the prospective parent’s physical, emotional, and financial aspects.
If you are a victim of the inefficient Bravelle, do not accept Ferring’s cheap, quick compensation. In doing so, you will sacrifice your right to get the full compensation for all your spent expenses and sufferings. Call Idaho Medical Malpractice Lawyer to consult about your legal options for free.
Bravelle is a prescription fertility drug produced by the company Ferring Pharmaceuticals to treat certain fertility problems in women. The drug is a purified form of a follicle-stimulating hormone (urofollitropin) used to aid in the maturing of the eggs for ovulation.
Bravelle (urofollitropin injection) is a drug that was approved in 2002 to treat female infertility. Swiss manufacturer Ferring Pharmaceuticals advertised that treatments could begin a woman’s “baby story.” The drug is a highly purified form of human follicle-stimulating hormone (FSH) that can stimulate egg maturation and increase the potential for pregnancy.
Unfortunately, batches of Bravelle failed to meet the 24-month shelf-life guarantee and the company began recalling Bravelle in 2015.
Bravelle is a brand name for Urofollitropin, a hormone used during In-Vitro Fertilization (IVF). The medication is also used as an infertility treatment for stimulating the production and development of eggs or follicles in the ovaries.
Urofollitropin falls under gonadotropins. It has a follicle-stimulating hormone (FSH) that occurs naturally through secretion by the pituitary gland in both men and women. In women, FSH helps in stimulating the development and maturity of eggs. Bravelle is administered as a subcutaneous injection to assist the ovulation process hence increasing fertility.
In September 2015 Ferring Pharmaceuticals quietly initiated a Class 3 recall with the Food and Drug Administration. The recall was not announced to the public. Class 3 recalls are not safety recalls likely to cause adverse health consequences. They do not obligate manufacturers, the FDA, or medical providers to notify consumers. However; some pharmacies and clinics did notify patients of the recall. In October 2015 a company spokesperson announced that the company was temporarily pulling Bravelle from shelves because some batches of the drug sold in 2014 “did not meet potency specifications for their full 24-month shelf life.” Tests showed that the drug’s potency decreased at a more rapid rate than stated by the manufacturer, resulting in ineffective treatments and a lack of expected results.
However, the company’s September 2015 report to the FDA indicated that the drug failed to meet even 12-month shelf life. The FDA listed Bravelle as a “Subpotent Drug: Stability samples were confirmed to be out of specification for potency at the 12-month time point” (See FDA Enforcement Report for the week of October 21, 2015.)
The injection acts by causing ovulation induction. This might lead to ovarian hyperstimulation syndrome, electrolyte imbalance, hypotension, weight gain, and vascular complications. Other side effects reported with the use of Bravelle include:
Due to these risks, patients are required to undergo assessments throughout the entirety of the IVF treatment, which forces couples to sustain significant expenses due to travel to distant clinics. The IVF procedure is time-consuming and expensive, and it may require several cycles spanning over months.
Bravelle has had a severe negative impact on the lives of disappointed or injured users. Women are learning that the expensive, painful injections they received were virtually worthless and that windows of time and opportunity have been squandered. Many have gone into debt for the high cost of Bravelle treatments, which can cost over $100 a day for many months. As if the financial burden weren’t enough, increasing dosages given over an extended period of time may increase the chance of risky side effects and limit future fertility treatments to more expensive, invasive options. Bravelle side effects can include:
Although the drug manufacturer recalled the defective lots voluntarily and offered reimbursement to the patients who used them, most families were left wondering whether the injection was effective or not.
Because a full IVF treatment might need several cycles, the cost might mount up to much more than only the little thousands of dollars provided by Ferring as compensation if the injection is defective. Additionally, the pharmaceutical corporation’s website did not warn about the possibility of not getting pregnant because of the lack of Bravelle effectiveness in most of the lots. Not only did a lot of women and their families lose money and suffer emotionally due to infertility, but they also placed themselves at risk for life-threatening side effects.
If you did not conceive after one or more complete cycles of Bravelle between March 2014 and October 2015, our Idaho Medical Malpractice Lawyer could help you seek full compensation for the entire treatment costs. Call us today for free legal consultation.
While all fertility drugs carry significant risks, women who have experienced side effects or ineffective treatment while taking Bravelle may have claims against the manufacturer. The Litster Frost legal team has been successful in getting compensation for victims from wealthy companies that failed to test their products or to warn consumers. Often companies have continued to sell products and reap billions in profits, even after they learned patients were being harmed.
We believe in accountability and injustice for those who have been harmed. We want to help if you have used Bravelle and have been harmed physically, emotionally, or financially. Please call us toll-free at (208) 333-3330 or fill out the form below to learn more about a path toward possible compensation.
Litster Frost Injury Lawyers is accepting Bravelle cases in all 50 states and Canada. If you or someone you know has been treated with Bravelle, please contact us immediately for a free consultation. Call toll-free at (208) 333-3330 fill out the contact form on this page or click the live chat button.
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